Approval · Notice of Compliance 28246 · 2022
LORBRENA: Notice of Compliance 28246
Issued May 20, 2022
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 28246
- Date
- May 20, 2022
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revision to the indication. Fulfillment of the post-approval commitments for the Notice of Compliance with conditions.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LORBRENA | Not yet assigned | — |
Medicinal ingredients
- LORLATINIB 25 MG per TAB
- LORLATINIB 100 MG per TAB